Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer

Recruiting now · Not applicable

Conditions studied: Colorectal Liver Metastasis

In brief

the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated colorectal liver metastasis (CRLM).

Key facts

Study ID

NCT04678583

Run by

Technische Universität Dresden

People needed

240

Starts

2021-01-01

Expected to finish

2027-12-01

Last updated by the study team

2024-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Colorectal cancer with RAS mutation (KRAS or NRAS)
• Colorectal liver metastases (single or multiple)
• Planned R0 resection of liver metastases (and primary tumor, if present)
• Anatomical and non-anatomical liver resection technically feasible
• Male and female patients, age ≥ 18 years
• Written informed consent

You may not qualify if…

• Extrahepatic metastases
• Planned staged liver resection (e.g. two-stage hepatectomy)
• Diagnosis of another cancer < 5 years prior to randomization Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer
• Expected lack of compliance
• Addiction or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences

Where it is running

• Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg — Würzburg, Germany (enrolling)
• Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden — Dresden, Saxony, Germany (enrolling)
• Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach — Ansbach, Germany (enrolling)
• Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital — Augsburg, Germany (enrolling)
• Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin — Berlin, Germany (enrolling)
• Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn — Bonn, Germany (enrolling)
• Surgical Clinic, Municipal Hospital Braunschweig gGmbH — Braunschweig, Germany (enrolling)
• Cancer Center, Helios Amper-Hospital Dachau — Dachau, Germany (enrolling)
• Surgical Clinic, Dortmund Hospital — Dortmund, Germany (enrolling)
• Clinic for General and Visceral Surgery, Municipal Hospital Dresden — Dresden, Germany (enrolling)
• Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf — Düsseldorf, Germany (enrolling)
• Surgical Clinic, University Hospital Erlangen — Erlangen, Germany (enrolling)
• Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main — Frankfurt, Germany (enrolling)
• Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg — Freiburg im Breisgau, Germany (enrolling)
• JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery — Giessen, Germany (enrolling)
• Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University — Göttingen, Germany (enrolling)
• Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald — Greifswald, Germany (enrolling)
• University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale) — Halle, Germany (enrolling)
• Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek — Hamburg, Germany (enrolling)
• Clinic for General, Visceral and Minimally Invasive Surgery, KRH Clinic Siloah, Hannover — Hanover, Germany (enrolling)
• Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery — Hanover, Germany (enrolling)
• Department of General, Visceral and Transplantation Surgery, University of Heidelberg — Heidelberg, Germany (enrolling)
• General Visceral and Vascular Surgery, Jena University Medical Center — Jena, Germany (enrolling)
• Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus — Lübeck, Germany (enrolling)

Full record on ClinicalTrials.gov

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